精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.943253443252473255063258393258883255650.09
29.863244153250423247280.14
单位质量响应值RSD%判断
32753.0232933.870.39数据可信
供试品溶液-2023091921批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1115107-11510759.80566.037.6459.8066.037.64
2139323-13932372.38772.39
3127493-12749366.24066.24
4136130-13613070.72870.73
5127176-12717666.07666.08
6117334-11733460.96260.96
10min1183616-18361695.39997.122.9395.5097.222.93
2192882-192882100.214100.33
3187435-18743597.38497.49
4190498-19049898.97599.09
5177764-17776492.35992.47
6189315-18931598.36098.46
15min1190583-19058399.01998.942.1199.2899.222.12
2194434-194434101.020101.31
3191391-19139199.43999.71
4192007-19200799.759100.04
5182685-18268594.91695.18
6191537-19153799.51599.78
20min1191981-19198199.74698.981.88100.1799.411.88
2194435-194435101.021101.48
3189620-18962098.51998.96
4192009-19200999.760100.21
5183949-18394995.57295.99
6190995-19099599.23399.66
30min1192692-192692100.11599.251.58100.7099.851.59
2194375-194375100.989101.61
3190176-19017698.80899.41
4192244-19224499.882100.50
5185616-18561696.43997.02
6191016-19101699.24499.84
极限1193687-193687100.63299.781.67101.39100.551.67
2197317-197317102.518103.31
3190812-19081299.13899.91
4191781-19178199.642100.42
5187819-18781997.58398.33
6190906-19090699.18799.95
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.943244343250053254133252393255243251230.14
29.863246633244043245340.06
单位质量响应值RSD%判断
32708.5532914.200.45数据可信
供试品溶液-2023091921批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1147543-14754376.73263.4714.1276.7363.4714.12
2119939-11993962.37762.38
3119733-11973362.26962.27
4136241-13624170.85570.85
5103861-10386154.01554.01
6104955-10495554.58454.58
10min1188042-18804297.79597.602.6697.9297.712.66
2192447-192447100.086100.19
3180230-18023093.73293.84
4191952-19195299.82899.95
5183112-18311295.23195.32
6190242-19024298.93999.03
15min1188375-18837597.96899.642.6698.2699.912.66
2199216-199216103.606103.88
3184000-18400095.69395.95
4192386-192386100.054100.34
5192894-192894100.318100.57
6192635-192635100.183100.44
20min1188152-18815297.85299.621.6098.31100.061.59
2194535-194535101.172101.62
3187458-18745897.49197.91
4192225-19222599.970100.42
5194419-194419101.111101.53
6192536-192536100.132100.55
30min1187613-18761397.57299.631.9198.19100.231.90
2195007-195007101.417102.03
3186783-18678397.14097.72
4191845-19184599.773100.39
5195394-195394101.618102.20
6192785-192785100.261100.85
极限1187325-18732597.42299.861.9198.20100.631.90
2195109-195109101.470102.25
3188573-18857398.07198.81
4191343-19134399.511100.30
5196732-196732102.314103.07
6193056-193056100.402101.16
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.943243213245113246023244543243343244440.04
29.863238813241533240170.06
单位质量响应值RSD%判断
32640.2432861.760.48数据可信
供试品溶液-2023092021批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1117830-11783061.39376.8911.8461.3976.8911.84
2148009-14800977.11777.12
3153092-15309279.76579.77
4148207-14820777.22077.22
5172224-17222489.73489.73
6146102-14610276.12376.12
10min1179896-17989693.73198.673.6893.8398.803.69
2181965-18196594.80994.94
3189257-18925798.60898.74
4195976-195976102.109102.24
5194344-194344101.259101.41
6194797-194797101.495101.62
15min1187129-18712997.499100.252.3497.76100.542.34
2187872-18787297.88798.17
3190381-19038199.19499.49
4196861-196861102.570102.87
5195545-195545101.884102.20
6196694-196694102.483102.78
20min1190170-19017099.084100.681.5699.50101.141.57
2190466-19046699.23899.69
3190920-19092099.47599.94
4196621-196621102.445102.91
5195782-195782102.008102.50
6195436-195436101.828102.29
30min1191800-19180099.933100.841.37100.52101.471.38
2190987-19098799.510100.12
3190782-19078299.403100.03
4196245-196245102.249102.89
5196344-196344102.301102.96
6195126-195126101.666102.30
极限1192931-192931100.522100.871.36101.28101.671.36
2190792-19079299.408100.19
3190329-19032999.16799.96
4195683-195683101.956102.77
5196043-196043102.144102.97
6195822-195822102.029102.83
精氨酸培哚普利片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.943258543251643256443254623256143255480.08
29.863250413250363250380.01
单位质量响应值RSD%判断
32751.3132965.310.47数据可信
供试品溶液-2023092021批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1145939-14593975.79074.779.1475.7974.779.14
2155352-15535280.67880.68
3155312-15531280.65880.66
4128545-12854566.75766.76
5126654-12665465.77565.77
6151999-15199978.93778.94
10min1183199-18319995.140100.553.3195.27100.673.31
2196060-196060101.819101.95
3198337-198337103.002103.14
4188120-18812097.69697.81
5197733-197733102.688102.80
6198191-198191102.926103.06
15min1188699-18869997.996102.102.1398.28102.392.13
2198023-198023102.839103.14
3198907-198907103.298103.60
4195333-195333101.442101.72
5200163-200163103.950104.23
6198491-198491103.082103.38
20min1189615-18961598.472102.351.9398.92102.811.93
2198775-198775103.229103.70
3198918-198918103.303103.78
4196868-196868102.239102.68
5200068-200068103.901104.35
6198208-198208102.935103.41
30min1190760-19076099.067102.481.7099.68103.111.70
2199057-199057103.376104.02
3198630-198630103.154103.80
4197460-197460102.546103.16
5200055-200055103.894104.52
6197977-197977102.815103.46
极限1192686-192686100.067102.581.31100.84103.381.31
2198974-198974103.332104.15
3199004-199004103.348104.17
4197556-197556102.596103.38
5199836-199836103.780104.58
6197122-197122102.371103.19
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